Table 3. Summary of adverse events.

			Sex Subgroups		Age Subgroups		Study Site Subgroups
		All Subjects	Male	Female	Pediatric	Adult	Site 1	Site 2
		(N = 119)	(N = 70)	(N = 49)	(N = 58)	(N = 61)	(N = 80)	(N = 39)
Category	Type of Adverse Event	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Adverse events, n (%)	Any adverse event a	34 (28.6)	17 (24.3)	17 (34.7)	15 (25.9)	19 (31.1)	24 (30.0)	10 (25.6)
	Severe or life-threatening b	2 (1.7)	1 (1.4)	1(2.0)	0	2 (3.3)	1 (1.3)	1 (2.6)
	Led to premature discontinuation of study drug	1 (0.8)	0	1(2.0)	0	1 (1.6)	1 (1.3)	0
	Serious, including events leading to death	4 (3.4)	2 (2.9)	2 (4.1)	1 (1.7)	3 (4.9)	3 (3.8)	1 (2.6)
Death, n (%)		1 (0.8)	0	1(2.0)	0	1 (1.6)	1 (1.3)	0

The Safety population includes all subjects who received ≥1 dose of study drug. Subjects with multiple occurrences of the same event are counted only once.

^a One event of pyrexia reported in an adult male at site 2 was not treatment emergent.

^b Grade 3 or 4 according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTEP-CTCAE) definition.